Quality Engineer
Location: Phillipsburg, NJ Type: Contract
Compensation: $40 - $45 hourly
Contractor Work Model: Onsite Quality Engineer
6 month assignment. Maybe longer
- Possesses knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and international medical device regulations (MDR)
- Understands Sterilization qualification and maintenance as it relates to medical devices
- Ensures compliance to QSR and GMP in assigned areas
- Manage corrective and preventive action process from investigation through effectiveness checks
- Maintain Design History and Technical Files, and documentation for internal and external audits
- Organizes and prioritizes assigned tasks to ensure project meets expectations and timelines
- Create and execute department and company training
- Review Validation Protocols and Reports
- Utilizes Quality tools such as FMEA, Control Plan, and Process Flow
- Background in Risk Management a plus
- Possesses competent technical writing skills
- Education: Bachelor’s Degree in Engineering or related field of study
- Skills/Licensure: Computer skills (Microsoft, Excel, Word, etc.), Verification and Validation, proficiency in communicating (verbal and written) in English
- Experience: Equivalent work experience in an ISO regulated/Medical Device related background
- Physical Demands: Standing/Sitting, working at computer for normal periods
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